(109 days)
Not Found
No
The device description and performance studies focus on the physical properties, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML technology.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or cure a disease or condition.
No
The device is a personal lubricant intended to enhance sexual activity, not to diagnose any medical condition.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its chemical composition, packaging, and physical properties, with no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description details a silicone-based lubricant in a bottle. There is no mention of components designed to interact with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a disease or condition
- Using reagents or test strips
The testing described (biocompatibility, condom compatibility, stability) is relevant to a topical medical device for personal use, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
A personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.
Product codes
NUC
Device Description
The Trojan™ Riviera™ Personal Lubricant is an anhydrous, clear silicone-based personal lubricant with fragrance that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.
The Riviera™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packaged in a carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009.
Test Performed: Cytotoxicity, Results: Mild Reactivity (Grade 2)
Test Performed: Acute Systemic Toxicity, Results: Non-systemically toxic
Test Performed: Primary Rabbit Skin Irritation, Results: Negligible irritant
Test Performed: Rabbit Vaginal Irritation, Results: Non-irritant
Test Performed: Rabbit Penile Irritation, Results: Non-irritant
Test Performed: Guinea Pig Maximum Sensitization, Results: Non-sensitizer
Condom Compatibility Testing was performed with Riviera™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)-subject lubricant.
Condom compatibility testing demonstrates that Riviera™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.
Shelf Life: Riviera™ Personal Lubricant has a two year shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count, Total Yeast and Mold count, and Absence of Pathogens. The results were satisfactory for all parameters. A real-time stability study is being performed in order to verify results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird or eagle with three human profiles incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2015
Charles & Dwight Co., Inc. Lisa Burns Senior Regulatory Affairs Specialist 500 Charles Ewing Blvd. Ewing. NJ 08628
Re: K150886 Trade/Device Name: Trojan Riviera Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 22, 2015 Received: June 23, 2015
Dear Lisa Burns,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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3
II. 510(k) Summary Trojan™ Riviera™ Personal Lubricant
| Submitter Name: | Church & Dwight Co., Inc. |
|---|---|
| Submitter Address: | 500 Charles Ewing Boulevard |
| Ewing, NJ 08628 | |
| Contact Person: | Lisa Burns |
| Senior Regulatory Affairs Specialist | |
| Church & Dwight Co., Inc. | |
| 469 North Harrison Street | |
| Princeton, NJ 08543 | |
| Tel: (609) 806.1997 | |
| Fax: (609) 403.7411 | |
| Date Prepared: | March 31, 2015 |
| Device Trade Name: | Trojan™ Riviera™ Personal Lubricant |
| Device Common Name: | Personal Lubricant |
| Product Code: | NUC - Condom (21 CFR § 884.5300) |
| Classification: | Class II |
| Predicate Device: | Trojan™ Tingly Warmth Personal Lubricant (K120706) |
| Intended Use: | A personal lubricant for penile and/or vaginal application, |
| intended to lubricate and moisturize, to enhance the ease and | |
| comfort of intimate sexual activity and supplement the body's | |
| natural lubrication. The product is compatible with natural | |
| rubber latex and polyisoprene condoms. Not compatible with | |
| polyurethane or other condoms. |
Device Description:
The Trojan™ Riviera™ Personal Lubricant is an anhydrous, clear silicone-based personal lubricant with fragrance that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.
The Riviera™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packaged in a carton.
4
Technological Characteristics:
There is no difference in the fundamental technological characteristics of Riviera™ Personal Lubricant and the predicate Trojan™ Tingly Warmth Personal Lubricant (K120706). The 510(k)-subject device contains a similar silicone base as the legally marketed predicate, and the addition of fragrance does not raise new questions of safety or effectiveness.
Biocompatibility:
Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009.
| Test Performed | Results |
|---|---|
| Cytotoxicity | Mild Reactivity (Grade 2) |
| Acute Systemic Toxicity | Non-systemically toxic |
| Primary Rabbit Skin Irritation | Negligible irritant |
| Rabbit Vaginal Irritation | Non-irritant |
| Rabbit Penile Irritation | Non-irritant |
| Guinea Pig Maximum Sensitization | Non-sensitizer |
Condom compatibility:
Condom Compatibility Testing was performed with Riviera™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)-subject lubricant.
Condom compatibility testing demonstrates that Riviera™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.
Shelf Life:
Riviera™ Personal Lubricant has a two year shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count, Total Yeast and Mold count, and Absence of Pathogens. The results were satisfactory for all parameters.
A real-time stability study is being performed in order to verify results.
5
Substantial Equivalence:
Based on non-clinical performance data, biocompatibility review and testing and safety data, Riviera™ Personal Lubricant is substantially equivalent to the predicate device, Trojan™ Tingly Warmth Personal Lubricant in technology, intended use, safety and effectiveness.